parallel randomized trial

NCT03520972

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT03520972S002761

Design

Randomized: 251
Start year: 2018
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (31 sites)
Sponsor: PegBio Co., Ltd. (mixed)
Eligibility: age 18 to 70; BMI 18.5 to 35; HbA1c 7.5 to 11.0 percent; drug naive 3 months on diet and exercise

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet and exercise; lifestyle: not reported	62	62
A2	PEG-loxenatide 75 µg injection once weekly PB-119 75 ug once weekly	diet and exercise; lifestyle: not reported	63	62
A3	PEG-loxenatide 150 µg injection once weekly PB-119 150 ug once weekly	diet and exercise; lifestyle: not reported	63	63
A4	PEG-loxenatide 200 µg injection once weekly PB-119 200 ug once weekly	diet and exercise; lifestyle: not reported	63	63

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	PEG-loxenatide 75 µg injection once weekly A2	PEG-loxenatide 150 µg injection once weekly A3	PEG-loxenatide 200 µg injection once weekly A4
age: 18 to 49	n	30	24	30	26
age: 18 to 49	percent	48.4	38.7	47.6	41.3
age: 50 to 70	n	32	38	33	37
age: 50 to 70	percent	51.6	61.3	52.4	58.7
age	mean (years)	50.7	50.8	51.4	50.5
age	sd (years)	10.81	8.93	9.77	10.24
diabetes duration: 3 or less	n	49	41	39	35
diabetes duration: 3 or less	percent	79	66.1	61.9	55.6
diabetes duration: more than 10	n	3	8	7	4
diabetes duration: more than 10	percent	4.8	12.9	11.1	6.3
diabetes duration: more than 3 to 10	n	10	13	17	24
diabetes duration: more than 3 to 10	percent	16.1	21	27	38.1
diabetes duration	mean (years)	2.66	3.20	3.28	3.48
diabetes duration	sd (years)	3.922	4.312	3.949	4.443
female	n	25	14	22	32
female	percent	40.3	22.6	34.9	50.8
hba1c: 8.5 to 9.5	n	31	21	20	26
hba1c: 8.5 to 9.5	percent	50	33.9	31.7	41.3
hba1c: less than 8.5	n	24	32	27	29
hba1c: less than 8.5	percent	38.7	51.6	42.9	46
hba1c: more than 9.5	n	7	9	16	8
hba1c: more than 9.5	percent	11.3	14.5	25.4	12.7
hba1c	max (percent)	10.5	10.9	10.9	11.1
hba1c	mean (percent)	8.74	8.57	8.77	8.65
hba1c	median (percent)	8.75	8.40	8.70	8.50
hba1c	min (percent)	7.5	7.3	6.9	7.2
hba1c	sd (percent)	0.708	0.842	0.951	0.788
other ethnicity han	n	62	61	62	61
other ethnicity han	percent	100	98.4	98.4	96.8
other ethnicity other	n	0	1	1	2
other ethnicity other	percent		1.6	1.6	3.2

Analyses this trial contributes to

Results

56 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (14 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.41 percent	0.745		62	not stated; full analysis; R0011873:Table 2
12	A1	change	-0.39 percent		-0.60 to -0.19	62	not stated; full analysis; R0011873:Table 2
12	A2	change	-1.11 percent		-1.32 to -0.91	62	not stated; full analysis; R0011873:Table 2
12	A2	change	-1.18 percent	0.836		62	not stated; full analysis; R0011873:Table 2
12	A2 vs A1	md	-0.72 percent		-1.01 to -0.43		not stated; full analysis; R0011873:Table 2
12	A3	change	-1.57 percent		-1.78 to -1.37	63	not stated; full analysis; R0011873:Table 2
12	A3	change	-1.62 percent	1.014		63	not stated; full analysis; R0011873:Table 2
12	A3 vs A1	md	-1.18 percent		-1.47 to -0.89		not stated; full analysis; R0011873:Table 2
12	A3 vs A2	md	-0.46 percent		-0.74 to -0.17		not stated; full analysis; R0011873:Table 2
12	A4	change	-1.41 percent		-1.61 to -1.20	63	not stated; full analysis; R0011873:Table 2
12	A4	change	-1.33 percent	0.810		63	not stated; full analysis; R0011873:Table 2
12	A4 vs A1	md	-1.02 percent		-1.30 to -0.73		not stated; full analysis; R0011873:Table 2
12	A4 vs A2	md	-0.29 percent		-0.59 to 0.00		not stated; full analysis; R0011873:Table 2
12	A4 vs A3	md	0.17 percent		-0.12 to 0.45		not stated; full analysis; R0011873:Table 2

HbA1c below 7 percent (10 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	responders			5 / 62	not stated; full analysis; R0011873:Table 3
12	A2	responders			29 / 62	not stated; full analysis; R0011873:Table 3
12	A2 vs A1	or	10.02	3.54 to 28.38		not stated; full analysis; R0011873:Table 3
12	A3	responders			30 / 63	not stated; full analysis; R0011873:Table 3
12	A3 vs A1	or	10.36	3.67 to 29.30		not stated; full analysis; R0011873:Table 3
12	A3 vs A2	or	1.03	0.51 to 2.09		not stated; full analysis; R0011873:Table 3
12	A4	responders			26 / 63	not stated; full analysis; R0011873:Table 3
12	A4 vs A1	or	8.01	2.82 to 22.73		not stated; full analysis; R0011873:Table 3
12	A4 vs A2	or	0.80	0.39 to 1.62		not stated; full analysis; R0011873:Table 3
12	A4 vs A3	or	0.77	0.38 to 1.56		not stated; full analysis; R0011873:Table 3

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Table 4
A1	events	0 / 62	not stated; safety; R0011873:Results
A2	events	6 / 62	not stated; safety; R0011873:Table 4
A2	events	0 / 62	not stated; safety; R0011873:Results
A3	events	0 / 63	not stated; safety; R0011873:Results
A3	events	7 / 63	not stated; safety; R0011873:Table 4
A4	events	4 / 63	not stated; safety; R0011873:Table 4
A4	events	0 / 63	not stated; safety; R0011873:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	Detail
12	A1	change	-2.4 mmHg	not stated; other; R0011873:Results
12	A2	change	-1.5 mmHg	not stated; other; R0011873:Results
12	A3	change	-2.7 mmHg	not stated; other; R0011873:Results
12	A4	change	-2.9 mmHg	not stated; other; R0011873:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Results
A2	events	0 / 62	not stated; safety; R0011873:Results
A3	events	0 / 63	not stated; safety; R0011873:Results
A4	events	0 / 63	not stated; safety; R0011873:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Table 4
A2	events	0 / 62	not stated; safety; R0011873:Table 4
A3	events	0 / 63	not stated; safety; R0011873:Table 4
A4	events	0 / 63	not stated; safety; R0011873:Table 4

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Table 4
A2	events	1 / 62	not stated; safety; R0011873:Table 4
A3	events	1 / 63	not stated; safety; R0011873:Table 4
A4	events	1 / 63	not stated; safety; R0011873:Table 4

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Table 4
A2	events	4 / 62	not stated; safety; R0011873:Table 4
A3	events	10 / 63	not stated; safety; R0011873:Table 4
A4	events	21 / 63	not stated; safety; R0011873:Table 4

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0011873:Table 4
A2	events	1 / 62	not stated; safety; R0011873:Table 4
A3	events	8 / 63	not stated; safety; R0011873:Table 4
A4	events	14 / 63	not stated; safety; R0011873:Table 4